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Health Canada Reviewing Actos - Bladder Cancer Risk

Jun 17, 2011 | Parker Waichman LLP

Health Canada is the latest regulator to take up the issue of Actos and bladder cancer.  The Canadian agency announced today that it was beginning an Actos safety review after studies indicated it may put users at risk for bladder cancer.  Health Canada's move follows decisions in Germany and France to suspend sales of the drug, and an announcement from the Food & Drug Administration (FDA) that the U.S. label for Actos would be modified to reflect this potential side effect.

Two studies have recently pointed to an association between Actos and bladder cancer. In a Drug Safety Communication issued yesterday, the FDA said its analysis of five-year data from a decade-long study that indicated people with the longest exposure to and the highest cumulative dose of Actos were at greater risk of bladder cancer.  However, the data did not indicate an overall increased risk.

A week prior to that, France and Germany suspended sales of Actos after a study commissioned by the French government found that people taking Actos had a 22 percent higher risk of bladder cancer compared to those taking other drugs. Those taking the highest cumulative dose - 28,000 mg or more - faced the highest risk. The study followed 155,000 people taking Actos in France from 2006 to 2009 and 1.3 million other diabetics.

According to Health Canada, post-marketing reports of bladder cancer have been reported very rarely with the use of Actos. This information is included in the Canadian Product Monograph.  The agency said it is closely monitoring and has been reviewing all relevant studies on an ongoing basis.  If its review identifies new safety information, Health Canada said it will take appropriate action as necessary.

For now, Health Canada says the benefits of Actos are considered to outweigh the risks when used as directed in the Canadian Product Monograph. Patients with questions or concerns about their diabetes treatment should talk to their physician or pharmacist.

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